Senior Manager Regulatory Affairs
TA Business Partner
- Full Service Division
About the role
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ICON is currently recruiting for a Senior Manager, Regulatory Affairs to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe—from biotech startups to big pharma—as well as the research firms that serve them. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.
The Senior Manager, Regulatory Affairs has responsibility to provide comprehensive regulatory services for clients requiring support for registration and maintenance activities in for pharmaceuticals, biologics, and other product types. This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients. The work will entail primarily working with Health Canada submissions and assessments.
This role is responsible for ensuring project/ program timelines and budgets are met and maintaining client relationships in support of future business. The role is responsible for support of activities to secure new clients/business. This position may or may not have direct reports.
The primarily responsibilities of this job include:
- Effectively-prepare regulatory files and provide support for maintenance activities in adherence with applicable legislation, and guidelines facilitating approvals and continued client compliance. Assess and update clinical and non-clinical sections of the dossier to meet Canadian requirements.
- Manages and ensures maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions.
- Lead/attend formal interactions (face-to-face meetings, teleconferences, etc.) with clients and, government agencies. Prepare pre-submission meeting requests, packages, and priority-review requests.
- Develops initial or alternative regulatory strategies consulting with other resources within the organization as needed. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
- Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Lead, participate in and support project teams related to regional filings and maintenance activities across a range of product types.
- Effectively prioritize and complete multiple projects within established timeframes.
- Proactively monitors for new regulatory requirements and shares key learnings.
- Train or mentor others to build team expertise across various product types.
- This role will prepare quotations for projects that may cross multiple service areas within the company and manage projects within budget preparing change orders as needed.
- Proactively improve business processes and tools to facilitate provision of core services.
- Ability to work off site at client occasionally may be needed.
- Ability to travel (10%) as necessary, passport required.
- Expectations and responsibilities as outlined in the Mapi Manager Job Description if direct reports as assigned.
- Provide business development support and presentation of services to clients.
Required experience:
- Undergraduate degree preferably in science, nursing or healthcare field or equivalent qualification/experience. Relevant advanced degree (M.Sc., Ph.D., M.D., Pharm.D, MBA) beneficial.
- Certification in regulatory affairs (RAC) or post-secondary institution is beneficial.
- Minimum eight years of relevant experience i.e. pharmaceutical, biologics.
- Experience in consulting, supporting business development activities and people management is beneficial.
Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
What’s Next?
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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